A multicenter, randomized, double-blind, placebo-controlled study of efficacy and safety of 3 doses of botulinum toxin A in the treatment of glabellar lines

• Published in: Journal of the American Academy of Dermatology 2004-08, Vol.51 (2), p.223-233
• Main Authors: Ascher, Benjamin, Zakine, Benjamin, Kestemont, Philippe, Baspeyras, Martine, Bougara, Ali, Santini, José
• Format: Article
• Language: English
• Subjects: Adult; Aged; Biological and medical sciences; Botulinum Toxins, Type A - administration & dosage; Botulinum Toxins, Type A - adverse effects; Dermatology; Double-Blind Method; Drug Administration Schedule; Facial Muscles; Female; Forehead; Humans; Male; Medical sciences; Middle Aged; Patient Satisfaction - statistics & numerical data; Photography; Skin Aging; Treatment Outcome
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2003.11.084

Botulinum toxin A (BTX-A) is used to treat glabellar lines but the rigorous demonstration of its efficacy in a well-designed study had never been reported. This study was designed to evaluate the efficacy and the safety of 3 doses of BTX-A in the treatment of glabellar lines. A total of 119 patients with moderate to severe glabellar lines at rest were treated with 25, 50, or 75 U of BTX-A (Dysport, Ipsen) or placebo divided into 5 intramuscular glabellar sites. Outcome measures included evaluations of glabellar lines by independent experts from blinded standardized photographs at rest 1 month after treatment, physician evaluations, and patient assessments during a 6-month period. A significant efficacy was reported for the 3 BTX-A groups for at least 3 months after injection (at least P < .015). Investigator and patient evaluations suggested that 50 U was the optimal dose. BTX-A was well tolerated. No blepharoptosis was reported. An evaluation in blinded conditions by independent experts was necessary because the results were overestimated by the investigators. BTX-A is an effective and safe treatment for glabellar lines.